MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) TENDRIL STS; NO MATCH

Model Number 2088TC/46

Device Problems Fracture (1260); Low impedance (2285); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/14/2023

Event Type  malfunction  

Event Description

It was reported that patient presented for implant procedure.During procedure it was noted that the atrial lead exhibited low pacing impedance and a crimp proximal to the suture sleeve suggesting the atrial lead had fractured.The procedure was completed using another lead.The patient was in stable condition,.

Manufacturer Narrative

The reported events were low pacing impedance, ¿a crimp just proximal to the suture sleeve was noted¿ and lead fracture.As received, a complete lead was returned in one piece.The reported events of low pacing impedance and ¿a crimp just proximal to the suture sleeve was noted¿ were confirmed.Visual and x-ray examination of the lead found the outer coil was damaged at the proximal region of the lead due to procedural damage.An internal short was found between the inner coil and outer coil conductor paths due to the damaged outer coil at the proximal region of the lead.The cause of the reported event of low pacing impedance and ¿a crimp just proximal to the suture sleeve was noted¿ was due to procedural damage causing internal shorting.The reported event of lead fracture was not confirmed.Visual and x-ray examination of the lead did not find any anomalies with the exception of procedural damage.No lead fracture was found.

• Brand Name: TENDRIL STS
• Type of Device: NO MATCH
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 17865869
• MDR Text Key: 324883808
• Report Number: 2017865-2023-47243
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 05414734502870
• UDI-Public: 05414734502870
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P960013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2088TC/46
• Device Lot Number: P000172189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/03/2023
• Supplement Dates Manufacturer Received: 10/11/2023; 10/26/2023
• Supplement Dates FDA Received: 10/25/2023; 11/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Male